Boron Neutron Capture Therapy With B10 L-BPA for Unresectable Recurrent Head and Neck Cancers

NCT06952868 | Recruiting Phase 2

• 1 other identifier: CMUH114-REC1-042
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

This Phase II study, titled "A Phase II Study to Evaluate the Efficacy and Safety of Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Patients with Unresectable Recurrent Head and Neck Cancers," aims to assess the efficacy and safety of B10 L-BPA-based BNCT in this patient population. The primary objective is to evaluate its efficacy, while secondary objectives include assessing safety, survival outcomes, tumor response, and the pharmacokinetics (PK) profile of B10 L-BPA and boron.

Conditions

Head and Neck Cancer; Boron Neutron Capture Therapy

Keywords

phase II; B10 L-BPA; BNCT

Outcome Measures

Primary Outcomes (1)

• Assessment of the Efficacy of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers

  The objective response rate (ORR) of the B10 L-BPA-based BNCT, as evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. ORR is defined as the proportion of subjects whose best overall response is either complete response (CR) or partial response (PR) of the target lesions.

  6 months

Secondary Outcomes (11)

• Evaluation of the Safety of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers

  6 months

• Assessment of the Survival Status of B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers

  6 months

• Assessment of Tumor Responses to B10 L-BPA-Based BNCT in Unresectable Recurrent Head and Neck Cancers

  6 months

• Peak Plasma Concentration (Cmax)

  3 Days

• Time to Peak Plasma Concentration (Tmax)

  3 Days

Other Outcomes (1)

• Assessment of the Population of Circulating Immune Cells and Associated Cytokines Before and After B10 L-BPA-Based BNCT

  6 months

Study Arms (1)

Single arm treated by BNCT only

EXPERIMENTAL

Drug: Drug: B10 L-BPA Injection

Interventions

Drug: B10 L-BPA Injection DRUG

The investigational product is B10 L-BPA Injection, is a boron-containing compound in which 10B replaces a position on L-phenylalanine at the para position with dihydroxyboron. This single arm of the study is designed to evaluate the therapeutic efficacy of BNCT, wherein patients receive B10 L-BPA administration followed by neutron irradiation.

Single arm treated by BNCT only

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject aged 18-80 (inclusive).
• Histologically or cytologically confirmed diagnosis of head and neck cancers with no distant metastasis in subjects as follows:
• Unresectable recurrent or persistent squamous cell carcinoma (SCC) after completing one of the following frontline therapies:
• Standard concurrent chemoradiotherapy with a platinum-containing regimen.
• Curative induction chemotherapy with a platinum-containing regimen, followed by radiation therapy.
• Radiation therapy alone in the prior treatment for those who are unfit for a platinum-containing regimen or reject chemotherapy for the treatment of locoregional recurrence.
• Concurrent chemoradiotherapy with a cetuximab-containing regimen in the prior treatment for those who are unfit for a platinum-containing regimen or reject other chemotherapy for the treatment of locoregional recurrence.
• Unresectable recurrent or persistent non-squamous cell carcinoma (nSCC) after receiving any type of frontline therapies.
• Subjects who are unsuitable for systemic therapies, or subjects who refuse systemic therapies.
• Receipt of prior radiation therapy between 40 Gray (Gy) and 75 Gy at the target lesion(s) for SCC patients and no more than 75 Gy at the target lesion(s) for nSCC patients.
• There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
• There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.
• Measurable disease by magnetic resonance imaging (MRI) and/or computed tomography (CT) scan and ≤ 7 cm in the longest dimension.
• At least one measurable lesion that can be assessed by RECIST version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

You may not qualify if:

• Presence of secondary cancer with the exception of carcinoma in situ and skin cancers after curative surgery.
• Synchronous multiple head and neck cancers outside the field of neutron beam irradiation.
• Distant metastasis outside of the head and neck region.
• Imaging studies, e.g., CT, MRI, demonstrating tumor invasion into the carotid artery.
• Unsuitable for the BNCT, as assessed by the investigator based on the investigator-determined computed tomography angiography (CTA) of head and neck in suspected cases of tumor invasion into the carotid artery.
• Presence of any ≥ Grade 3 toxicity (e.g., mucositis, stomatitis, and skin inflammation) at the prior irradiation area, as assessed by the NCI-CTCAE version 5.0.
• Presence of ≥ Grade 3 cataract, as assessed by the NCI-CTCAE version 5.0.
• Active infections requiring systemic treatment within 2 weeks of the screening visit.
• Myocardial infarction, unstable angina, or poorly controlled arrhythmia within 6 months prior to the scheduled BNCT.
• Severe comorbidities including but not limited to poorly controlled epilepsy, poorly controlled diabetes mellitus, poorly controlled hypertension, chronic lung diseases, e.g., obstructive pneumonia, interstitial pneumonia, pulmonary fibrosis, and severe emphysema, kidney diseases, e.g., chronic renal failure, acute renal failure, and nephrotic syndrome, cardiac diseases, e.g., New York Heart Association (NYHA) Functional Classification Class III or IV, and/or other severe conditions in the opinion of the investigator.
• Suspected or known hypersensitivity (including allergy) to any of B10 L-BPA components (e.g., L-phenylalanine) or contrast media.
• History of prior BNCT.
• Subject with hereditary fructose intolerance.
• Subject with phenylketonuria.
• Presence of any dental conditions necessitating tooth extraction within 2 weeks before and after the BNCT, as assessed by the dentist.

Sponsors & Collaborators

• China Medical University Hospital: lead
• Heron Neutron Medical Corp.: collaborator

Study Sites (2)

China Medical University Hospital

Taichung, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hsopital, Taipei,

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, single-arm, Phase II clinical study.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 1, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

TW (2)